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001-es BibID:	BIBFORM042521
035-os BibID:	PMID:22124575
Első szerző:	Reginster, J-Y.
Cím:	Maintenance of antifracture efficacy over 10 years with strontium ranelate in postmenopausal osteoporosis / Reginster, J-Y., Kaufman, J-M., Goemaere, S., Devogelaer, J. P., Benhamou, C. L., Felsenberg, D., Diaz-Curiel, M., Brandi, M-L., Badurski, J., Wark, J., Balogh, A., Bruyère, O., Roux, C.
Dátum:	2012
ISSN:	0937-941X
Megjegyzések:	In an open-label extension study, BMD increased continuously with strontium ranelate over 10 years in osteoporotic women (P < 0.01). Vertebral and nonvertebral fracture incidence was lower between 5 and 10 years than in a matched placebo group over 5 years (P < 0.05). Strontium ranelate's antifracture efficacy appears to be maintained long term.INTRODUCTION:Strontium ranelate has proven efficacy against vertebral and nonvertebral fractures, including hip, over 5 years in postmenopausal osteoporosis. We explored long-term efficacy and safety of strontium ranelate over 10 years.METHODS:Postmenopausal osteoporotic women participating in the double-blind, placebo-controlled phase 3 studies SOTI and TROPOS to 5 years were invited to enter a 5-year open-label extension, during which they received strontium ranelate 2 g/day (n = 237, 10-year population). Bone mineral density (BMD) and fracture incidence were recorded, and FRAX? scores were calculated. The effect of strontium ranelate on fracture incidence was evaluated by comparison with a FRAX?-matched placebo group identified in the TROPOS placebo arm.RESULTS:The patients in the 10-year population had baseline characteristics comparable to those of the total SOTI/TROPOS population. Over 10 years, lumbar BMD increased continuously and significantly (P < 0.01 versus previous year) with 34.5 ? 20.2% relative change from baseline to 10 years. The incidence of vertebral and nonvertebral fracture with strontium ranelate in the 10-year population in years 6 to 10 was comparable to the incidence between years 0 and 5, but was significantly lower than the incidence observed in the FRAX?-matched placebo group over 5 years (P?<?0.05); relative risk reductions for vertebral and nonvertebral fractures were 35% and 38%, respectively. Strontium ranelate was safe and well tolerated over 10 years.CONCLUSIONS:Long-term treatment with strontium ranelate is associated with sustained increases in BMD over 10 years, with a good safety profile. Our results also support the maintenance of antifracture efficacy over 10 years with strontium ranelate.
Tárgyszavak:	Orvostudományok Klinikai orvostudományok idegen nyelvű folyóiratközlemény külföldi lapban
Megjelenés:	Osteoporosis International 23 : 3 (2012), p. 1115-1122. -
További szerzők:	Kaufman, J-M. Goemaere, Stefan Devogelaer, Jean-Pierre Benhamou, C. L. Felsenberg, Dieter Diaz-Curiel, M. Brandi, M-L. Badurski, Janusz E. Wark, J. Balogh Ádám (1940-) (szülész-nőgyógyász, endokrinológus szakorvos) Bruyère, Olivier Roux, Christian
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